MAUDE Adverse Event Report: HOLLISTER INCORPORATED VAPRO PLUS POCKET; VAPRO PLUS PKT HYDROPHILIC IC CH14 40CM

Model Number	71144-2-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Urinary Frequency / Polyuria (2275)
Date of Event	12/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No customer product sample available for investigation.Lot number provided so a dhr review was conducted.Dhr and sterilization records were found to be complete and accurate.No other complaint reports for this lot/sku combination.The root cause of the reported event could not be determined.Causation could not be established between the hollister urethral catheter and the reported symptoms.
Event or Problem Description
It was reported that an end user who is a paraplegic, noticed sediment in his urine and then 2 weeks later, developed symptoms including fever, aches, and urine leakage.It was further reported that the patient didn't see a doctor initially because the office was closed but took an at-home urine test and then took the antibiotic ciprofloxacin.It was further reported the end user keeps a supply of antibiotics at home for such cases.It was then reported when he did get in to see a health care professional two days later, the urine test at the doctor's office was negative.It was reported the end user continues to take the antibiotic (which is day at 7 of the 14-day course), and that his fever is down but he still leaks urine and has to catheterize every 200ml otherwise he leaks, and bladder becomes overactive.He reports he still has some sediment in urine, but it has decreased from the amount he had at the beginning of his symptoms.

• Brand Name: VAPRO PLUS POCKET
• Common Device Name: VAPRO PLUS PKT HYDROPHILIC IC CH14 40CM
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. IL 60048
• Manufacturer (Section G): HOLLISTER LIETUVA UAB; oro parko str. 2, sergeicikai; karmelavos; kauno raj., ltu LT-54 462; LH LT-54462
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville., IL 60046 ; 8479321271
• MDR Report Key: 21228452
• Report Number: 3016675012-2025-00001
• Device Sequence Number: 12835295
• Product Code: GBM
• UDI-Device Identifier: 00610075094479
• UDI-Public: (01)00610075094479(17)261001(30)30(10)4J109
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K233524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/01/2026
• Device Model Number: 71144-2-30
• Device Catalogue Number: 71144-2-30
• Device Lot Number: 4J109
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male